CKE · Class II · 21 CFR 862.1020

FDA Product Code CKE: Acid Phosphatase, Thymolphthale Inmonophosphate

Leading manufacturers include Data Medical Associates, Inc., Stanbio Laboratory and Diagnostic Chemicals, Ltd. (Usa).

9
Total
9
Cleared
66d
Avg days
1979
Since

FDA 510(k) Cleared Acid Phosphatase, Thymolphthale Inmonophosphate Devices (Product Code CKE)

9 devices
1–9 of 9
Cleared Mar 17, 1992
CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE
K914167
Eastman Kodak Company
Chemistry · 182d
Cleared Jan 27, 1988
ACID PHOSPHATASE TEST
K873726
King Diagnostics, Inc.
Chemistry · 134d
Cleared Nov 28, 1986
DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM
K864230
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 31d
Cleared Mar 05, 1986
ACID PHOSPHATASE REAGENT SET
K860476
Sterling Diagnostics, Inc.
Chemistry · 26d
Cleared Sep 20, 1984
ACID PHOSPHATASE ASSAY KIT
K843380
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Apr 16, 1980
STANBIO PROSTATIC ACID PHOSPHATASE TEST
K800693
Stanbio Laboratory
Chemistry · 20d
Cleared May 23, 1979
DATA-ZYME ACIA PHOSPHATASE PROCEDURE
K790524
Data Medical Associates, Inc.
Chemistry · 69d

About Product Code CKE - Regulatory Context